Kornimate/medical-research-clean huggingface dataset:
forecasts impact of the pre-therapeutic tep-tdm in the 18-fdg restaging of upper aero-digestive tract cancers

Conditions: Cancer of Head and Neck

Summary: head and neck (hn) cancer is the sixth most common malignancy worldwide, with around 800 000 new cases and 320 000 deaths in 2015. these malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (hnscc) 90% of the time. despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade. the prognosis is strongly dependent on initial staging. the 5-year relative survival rate is 80,3% for patients with localized disease whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when distant metastasis is known. hence, precise cancer staging is essential as it allows clinicians to select the appropriate treatment strategies and predict the prognosis of the patients. the conventional work-up (cwu) includes physical examination, endoscopy, computed tomography (ct) and/or magnetic resonance imaging (mri) of the head and neck to evaluate the initial local and regional hnscc staging. thoracic ct is recommended because the thorax is the most frequent location of remote metastasis and synchronous second cancer outside of the upper aerodigestive tract. some authors demonstrated that 18f-fluorodeoxyglucose (18f-fdg) positron emission tomography (pet) had a higher sensitivity and specificity for determining the extent of the disease and was able to detect occult second primaries. moreover 18-fdg pet-ct allows whole body assessment. this is why the use of 18-fdg pet-ct has increased significantly over the last several years. added to initial cwu, 18-fdg pet-ct may restage hnscc and as a result may alter the clinical management. pre-therapeutic 18f-fdg pet/ct is recommended by guidelines to assess remote extension of locally advanced hnscc and/or to look for synchronous cancer but is not systematically indicated, particularly for localized disease. restaging impact on prognosis and clinical management remains poorly understood. therefore, the objective of this study is to assess the impact of the additional information provided by 18f-fdg pet-ct on hnscc initial staging and whether restaging modify prognosis and clinical management, whatever the cwu stage.


Eligibility criteria:
inclusion criteria: * biopsy proven hsncc * written consent exclusion criteria: * previous head and neck malignancy

Keywords: squamous cell carcinoma fdg pet/ct initial staging clinical management prognosis
health information technology to reduce disparities in adolescent health outcomes: a pragmatic trial

Conditions: Sexually Transmitted Diseases

Summary: we will compare differences in sexually transmitted infection (sti) detection rates between sexual health survey (shs)-derived electronic clinical decision support (cds) versus usual care (e.g. no provision of cds) using an interrupted time series design. we hypothesize that population-based sti detection rates will be higher when shs-derived electronic cds is provided compared to usual care. secondary analysis will include a comparison of sti detection rates by sexual risk strata (high risk vs. at risk) and race/ethnicity.


Eligibility criteria:
inclusion criteria: * adolescents aged 15-21 years seeking care in the emergency department exclusion criteria: * patients will be excluded if unable to understand english, are critically ill, cognitively impaired, or otherwise unable to provide consent for completion of the sexual health survey (shs) and sti screening.
a multi-center, randomized, blinded evaluator, active control, parallel, phase iii study to evaluate the efficacy and safety of tjo-002 in poag or ocular hypertension patients

Conditions: Primary Open-angle Glaucoma; Ocular Hypertension

Summary: tjo-002 or acitve control was administered on primary open-angle glaucoma or ocular hypertension patients for 12 weeks. this clinical trial study has hypothesize tjo-002 administration groups are not inferior to active control administration groups.


Eligibility criteria:
* inclusion criteria: * male or female, age 19 or over * written informed consent to participate in the trial * exclusion criteria: * any other galucoma except poag(ex, closed anterior chamber angle, angle-closure glaucoma) * any laser or ocular surgery within 3months prior screening * use of contact lenses * known reactive airways disease * any condition limiting patient's ability to participate in the trial
yunzhi as dietary supplement in breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to assess the effects of a dietary supplement, the traditional asian mushroom yunzhi, as adjuvant in the treatment of patients with breast cancer.


Eligibility criteria:
inclusion criteria: 1. women with diagnosis of breast cancer 2. undergoing adjuvant/neoadjuvant chemotherapy with either fec, fac, tac, or ec + docetaxel combinations. 3. ≥ 18 years of age 4. performance status: 0-2 5. ability to provide written informed consent exclusion criteria: 1. any prior history of yunzhi use 2. use of other herbal remedies during the study duration 3. significant cardiac, pulmonary, renal, hepatic, gastrointestinal, cns, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation 4. pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization) 5. systemic use of progestins, androgens or other steroids (dexamethasone is allowed if used as antiemetic therapy)

Keywords: breast cancer undergoing adjuvant/neoadjuvant chemotherapy symptomatic therapy
effect of weighted blankets on anxiety for pediatric oncology patients

Conditions: Pediatric Cancer

Summary: the use of weighted blankets has been studied in the adult population but there is a lack of evidence to determine their benefit among a pediatric population, specifically oncology pediatric patients. pediatric oncology patients routinely experience anxiety during therapy and as cure rates increase, attention has progressively turned to treating psychosocial aspects of care.

a randomized 2x2 cross-over design will be utilized for this study. the study team will randomize participants to one of two sequences: 1) weighted blanket first then usual care or 2) usual care first then weighted blanket. the cross-over design allows the researchers to compare both within and between group differences. the advantages of the cross-over design allow minimize potential confounding bias as patients will serve as their own controls as well as potential for adequate power with smaller patient enrollment. as this study is conducted during chemotherapy treatments, the 30-day period in between patient treatments will be considered the washout period. this timeframe between chemotherapy infusions was chosen to try to capture patients in a similar state of baseline anxiety. this helps to provide adjustments to variability but should not limit accrual based on the number of patients that get chemotherapy within a 30-day period.

Eligibility criteria:
inclusion criteria: * newly diagnosed pediatric oncology patients between the ages of 4 and 17 receiving outpatient chemotherapy infusions in one of the two designated out patient locations (anschutz campus and colorado springs hospital) * patients who have a "liquid tumor" (leukemia or lymphoma), "solid tumor", or a neuro-oncologic diagnosis * patients who can complete the cam-s and cam-t as proven by seriation screening. * patients who are great than 13.5kg in weight, due to weighted blanket size options * patients whose second and third outpatient chemotherapy occur within 30 days of each other. * english and spanish speaking exclusion criteria: * patients who are younger than 4 years of age, or older than 17 years of age * relapsed patients * patients who are undergoing bone marrow transplant or had a previous bone marrow transplant * patients receiving chemotherapy infusions at north campus and south campus locations * patients in the inpatient setting * patients who utilize a weighted blanket at home currently or previously * patients who fail seriation screening during enrollment * patients who start initial chemotherapy infusions in the outpatient setting
the effect of korean version of peers social skills training for young adults (peers-ya-k) with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Autism

Summary: despite the psychosocial difficulties common among young adults with autism spectrum disorders(asd), little to no evidence-based social skills interventions exist for this population. using a randomized controlled trial(rct) design, the current study tested the effectiveness of an evidence-based, caregiver-assisted social skills intervention known as peers for young adults with high-functioning young adults with asd using self- and caregiver-report measures.

1. both the case and the control of this study shall be a high-functioning group consisting of young adults aged 18 to 35 years with asd and an iq of 70 or over. a total of 48 young adults will be recruited and divided into two groups. one will be the case group and the other will be the waitlist control group. and the study will be going on 3 institutions. again, the case will be divided into two sub-groups of ten and carry out this new developed program for both parents and young adult. that is, the program will be carried out two times in each of both groups. the waitlist control group will be allowed to receive personal outpatient treatment and general therapeutic intervention from community while waiting. 2. effects of the program will be measured both at the case and the control by using a scale which measures social interaction, quality of peer relationship, disposition of autism and social anxiety. equal assessments for both the case and the control will be conducted right before the beginning of the program and right after the completion of the program and four months after the completion of the program.

Eligibility criteria:
inclusion criteria: * 18\~35 years of age with asd and iq of 70 or over exclusion criteria: * young adults who are hard to understand the content of treatment and carry out the task due to their iqs or limited linguistic abilities * young adults who are uncooperative in the treatment, lack motives and are hard to participate voluntarily * young adults who have behavior problems so clinically significant that they affects the therapeutic procedure or problems in controlling their emotion and have psychotic symptoms

Keywords: social skill training peers
a pharmacokinetic study to evaluate the drug interaction between hrs5091 and probe drugs in healthy volunteers

Conditions: Chronic Hepatitis B

Summary: this is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect of hrs5091 on cyp3a4, cyp2c9, cyp2c19, p-gp, bcrp and oatp1b1, using midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin as probe drugs.


Eligibility criteria:
inclusion criteria: 1. the subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent; 2. healthy subjects aged 18\~50 (including 18 and 50 years old); 3. body weight ≥ 50 kg, body mass index (bmi) within the range of 19 \~ 26 kg /m2 (including 19 and 26 kg/m2) (bmi= weight (kg)/height2 (m2)); 4. give informed consent not to have a family plan for six months after the last dose, and agree to take effective contraception. exclusion criteria: 1. has the medicine or food allergy history, or is the allergic constitution person; 2. inability to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors affecting drug use and absorption; 3. qtcf \> 450 ms in 12-lead ecg examination or other abnormal conditions judged by the researchers to have clinical significance; 4. hepatitis b surface antigen (hbsag), hepatitis c virus antibody, human immunodeficiency virus (hiv) antibody, syphilis antibody test positive; 5. those who smoked more than 5 cigarettes per day within 3 months before screening and could not stop using any tobacco products during the trial period; 6. regular drinkers who had consumed more than 14 units of alcohol per week (1 unit = 285 ml of beer, 25 ml of spirits, or 100 ml of wine) during the six months prior to screening and could not stop using any alcoholic product during the trial; positive breath test for alcohol; 7. having a history of drug abuse, drug dependence (consultation) or positive urine drug abuse screening before drug administration; 8. anyone who has undergone any surgery within 6 months prior to screening; 9. clinical trial participants who have participated in any drug or medical device within 3 months prior to screening (subject to the intervention of the experimental drug or medical device);10.blood donation (or blood loss) within 3 months before screening and the amount of blood donation (or blood loss)≥400 ml, or receiving blood transfusion.
the safety and effectiveness of warfarin vs apixaban in patients with nvaf/ vte and eskd on dialysis

Conditions: End-Stage Kidney Disease (ESKD); Non-valvular Atrial Fibrillation (NVAF); Venous Thromboembolism (VTE)

Summary: this is a retrospective study of end-stage kidney disease (eskd) patients on dialysis receiving apixaban or warfarin at tawam hospital \[a tertiary care hospital in al ain, uae\]. the study aims to assess the appropriateness of prescribing apixaban and warfarin in this population and evaluate their safety and effectiveness.

direct oral anticoagulants (doacs), including apixaban, are used for stroke prevention in non-valvular atrial fibrillation (nvaf) and for venous thromboembolism (vte) management. patients with end-stage kidney disease (eskd) on dialysis face elevated risks of thromboembolic events and bleeding. while apixaban is fda-approved for use in this population, its safety and efficacy compared to warfarin are not well established in this vulnerable population. this retrospective observational study aims to assess the prescribing appropriateness of apixaban compared to warfarin and evaluate their safety and effectiveness in a cohort of eskd patients undergoing dialysis. this study will include eskd patients on dialysis receiving apixaban or warfarin at tawam hospital from may 1, 2018, to january 31, 2024. data on demographics, anticoagulant dosing, therapy duration, bleeding events, cha2ds2-vasc score, has-bled score, and thromboembolic events will be collected. safety will be assessed by bleeding incidents, and effectiveness will be measured by vte and stroke events. dose appropriateness was evaluated according to fda guidelines for apixaban and inr targets for warfarin. data will be collected for eligible patients through electronic medical records (emr).

Eligibility criteria:
inclusion criteria: * age more than 18 * ckd on dialysis for at least 1 month * nvaf or vte * on apixaban or warfarin for at least 1 month exclusion criteria: * age less than 18 * received dialysis for less than 1 month (i.e., were treated with dialysis for acute kidney injury). * on apixaban or warfarin for less than 1 month * pregnancy

Keywords: warfarin apaxiban
toleromune grass follow on study

Conditions: Rhinoconjunctivitis; Grass Allergy

Summary: grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. toleromune grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy. the purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to grass in the eeu among subjects who completed all dosing visits in study tg002 approximately two years after the start of treatment.

this is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled, parallel group clinical study (tg002) which evaluated the efficacy, safety and tolerability of three doses of toleromune grass versus placebo in grass allergic subjects. subjects who completed tg002 in calendar year 2012 will undergo a further single exposure to grass allergens in an eeu.

Eligibility criteria:
inclusion criteria: * previously randomised into study tg002, and completed all treatment visits and ptc during calendar year 2012 exclusion criteria: * "partly controlled" and "uncontrolled" asthama * history of anaphylaxis to grass allergen * fev1 \<80% of predicted * treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactuve drugs * symptoms of a clinically relevant illness * subjects who cannot tolerate allergen challenge in the eeu

Keywords: grass allergy rhinoconjunctivitis environmental exposure unit immunotherapy toleromune grass
duchenne muscular dystrophy clinical trial

Conditions: Duchenne Muscular Dystrophy

Summary: the primary objective of this investigation is to assess the effectiveness of transcutaneous electrical nerve stimulation applied using vecttor to reduce the symptoms of duchenne muscular dystrophy and reduce the impact of dmd upon the participants' quality of life. the primary outcome measures will include: 1. increased muscle strength, 2. increased range of joint motions and 3. improved sleep parameters of asi, n3 and rem.

muscle strength and joint range of motion testing - all muscle and joint testing was performed at the medcenter therapy clinic in houston, texas. jtech computerized testing system was utilized including goniometry, grip testing, inclinometry, muscle testing and joint range of motion testing occurred on day 0, 30, 60, 90, 180, and repeated at 12 months to determine muscular strength and joint range of motion. jtech computerized testing system was chosen on the basis of reliability and accuracy. at each of the testing intervals, the testing was administered by the same technician with the same equipment to all of the participants. inter-and intra-tester reliability of the jtech computerized testing system has been the subject of multiple studies. each of which found high iccs (\>0.93) for both inter- and intra-tester reliability. all sleep studies were performed at sleep diagnostics of texas in the woodlands, texas. prior to the clinical trial, all of the participants spent two nights in the sleep unit and their sleep study examinations were performed. the second night was used as the day 0 data. sleep, breathing, arousals and limb movements were scored manually according to guidelines set forth by the american academy of sleep medicine. the sleep studies were repeated at 6 months and 1 year.

Eligibility criteria:
inclusion criteria: * participants must have duchenne muscular dystrophy diagnosis as confirmed by licensed physician, wheelchair bound, \& age 8 - 20 years old. exclusion criteria: * active cancer in the area of application of the treatment, infection, skin infection, pregnancy, thrombophlebitis, pacemaker, amputation of any part of feet or hands, taking steroids. in addition, the participant may not be in any other clinical trial during the time they are in this study.
balancing method for pain related to advanced cancer

Conditions: Pain, Cancer; Metastatic Cancer; Invasive Cancer

Summary: balancing method for pain related to advanced cancer seeks to confirm the benefit of acupuncture for patients with pain related to advanced cancer.

pain is common among patients with cancer, with estimates as high as 90% for those with advanced disease. opioid medication, the most common treatment, has potential adverse effects including nausea and fatigue, further interfering with quality of life. acupuncture has been studied for the treatment of cancer-related pain, with promising results in a few methodologically sound studies with small sample size. prior studies have found beneficial effects of open treatment using a traditional chinese medicine (tcm)-based acupuncture protocol and dr. tan's balancing method. this open trial seeks to confirm the benefit of acupuncture, utilizing dr. tan's balancing method, for patients with pain related to advanced cancer.

Eligibility criteria:
inclusion criteria: 1. age 18 or older. 2. current diagnosis of a malignancy. 3. locally invasive, metastatic, or systemic involvement from the disease, which would be anticipated to produce pain. 4. average pain level, on a numeric rating scale, of 4/10 or higher on the numeric rating scale (nrs). 5. receiving treatment through hillman cancer center, magee hospital, or 1 of the university of pittsburgh cancer institute sites. 6. able to read and write english. exclusion criteria: 1. experience with acupuncture within the prior 3 months. 2. platelet count \< 50,000. 3. absolute neutrophil count \< 1,000. 4. treatment with anticoagulant medication, other than prophylactic levels of heparin or low molecular weight heparin preparations or anti-platelet agents. 5. known coagulopathy. 6. pregnancy. while it is unlikely that any patients undergoing advanced cancer treatment will be pregnant, given the lack of documented safety, this is an exclusion.

Keywords: acupuncture cancer pain